CYTOTEC misoprostol tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

misoprostol (UNII: 0E43V0BB57) (misoprostol - UNII:0E43V0BB57)

Доступна з:

Cardinal Health

ІПН (Міжнародна Ім'я):

misoprostol

Склад:

misoprostol 100 ug

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

New Drug Application

Характеристики продукта

CYTOTEC- MISOPROSTOL TABLET
CARDINAL HEALTH
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CYTOTEC
MISOPROSTOL TABLETS
WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT
CAN CAUSE BIRTH DEFECTS, ABORTION, OR PREMATURE BIRTH. UTERINE
RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN
PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE
EIGHTH WEEK OF PREGNANCY (see also PRECAUTIONS and LABOR AND
DELIVERY). CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO
REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDs) (see CONTRAINDICATIONS, WARNINGS, and
PRECAUTIONS).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED
NOT TO GIVE THE DRUG TO OTHERS.
Cytotec should not be used for reducing the risk of NSAID-induced
ulcers in women of
childbearing potential unless the patient is at high risk of
complications from gastric ulcers
associated with use of the NSAID, or is at high risk of developing
gastric ulceration. In such
patients, Cytotec may be prescribed if the patient
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DESCRIPTION
Cytotec oral tablets contain either 100 mcg or 200 mcg of misoprostol,
a synthetic prostaglandin E
analog.
Misoprostol contains approximately equal amounts of the two
diastereomers presented below with their
enantiomers indicated by (±):
Misoprostol is a water-soluble, viscous liquid.
Inactive ingredients of tablets are hydrogenated castor oil,
hypromellose, microcrystalline cellulose,
®
has had a negative serum pregnancy test within 2 weeks prior to
beginning therapy.
is capable of complying with effective contraceptive measures.
has received both oral and written warnings of the hazards of
misoprostol, the risk of
possible contraception failure, and the danger to other women of
childbearing potential
should the drug be taken by mistake.
will begin Cytotec only on the second or third day of the next normal
menstrual period.
1
and sodium starch glycolate.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Misoprostol is extensively absorbed, and undergoes rapid
de-esterification to its free ac